Foundayo (Orforglipron) Prescribing Information, Read for Patients
Foundayo (orforglipron) is FDA-approved, and its prescribing information is short on rules and long on dose steps. It is taken once a day, with or without food, at any time of day. The label carries the same boxed thyroid warning as the injectable GLP-1s and includes two interaction warnings that matter in daily life: one for birth control pills and one for a group of common drugs that change how the body clears orforglipron.
Key takeaways
- The FDA approved Foundayo on April 1, 2026, for chronic weight management in adults. As of October 2026 it has no type 2 diabetes indication.
- The label sets no food, water, or timing rules: one tablet daily, swallowed whole, "with or without food."
- Dosing starts at 0.8 mg and moves up in steps of at least 30 days. There are six strengths, and the top dose is 17.2 mg.
- Foundayo has a boxed warning for thyroid C-cell tumors, even though orforglipron did not cause tumors in rodents.
- Patients on birth control pills are told to switch methods or add a barrier method for 30 days after starting and after each dose increase.
What the FDA actually approved
The FDA approval letter for NDA 220934 is dated April 1, 2026. Lilly's medical information page confirms that date and says Foundayo is available through LillyDirect, telehealth providers, and US retail pharmacies. Eligible patients could get it starting April 9, 2026, according to Fierce Healthcare, and Foundayo was the first new molecular entity approved under the FDA's Commissioner's National Priority Voucher program.
The current prescribing information (revised July 2026) lists one indication. Foundayo is approved, alongside a reduced-calorie diet and more physical activity, to reduce excess body weight and maintain that reduction long term. It covers adults with obesity and adults with overweight who have at least one weight-related condition.
Orforglipron has been studied in type 2 diabetes in the ACHIEVE program, but the FDA approval history shows only the April 2026 weight-management approval as of this writing. The label does contain diabetes-related warnings because many people with obesity also have type 2 diabetes.
The label also includes a limitation of use: taking Foundayo together with another GLP-1 receptor agonist is "not recommended." That applies to semaglutide, tirzepatide, liraglutide, and the other GLP-1 products.
The dosing schedule, step by step
Foundayo comes in six tablet strengths. Each step lasts at least 30 days, and the prescriber picks the maintenance dose based on response and tolerability. This is how the label's dosage section lays it out.
| Step | Daily dose | Minimum time at this step | Tablet |
|---|---|---|---|
| Start | 0.8 mg | 30 days | Pink, round |
| 2 | 2.5 mg | 30 days | Light yellow, round |
| 3 | 5.5 mg | 30 days | Grayish purple, round |
| Maintenance options | 9 mg, 14.5 mg, or 17.2 mg | Chosen by response and tolerability | Pink, light yellow, or grayish purple modified oval |
| Maximum | 17.2 mg | n/a | Grayish purple modified oval |
Source: Foundayo US Prescribing Information, revised 7/2026.
The colors repeat across round and oval tablets: the 0.8 mg and 9 mg tablets are both pink, for example. The round tablets are debossed "L" with a G1 to G3 code, and the oval tablets are debossed "Lilly" with G4 to G6. Patients who are moving between doses can check the code on the tablet.
Clinical trials used a different set of numbers for orforglipron doses; the ATTAIN-MAINTAIN switching trial, for example, used 12 mg, 24 mg, and 36 mg. The label reports its pooled trial safety data under the marketed strengths of 5.5 mg, 9 mg, and 17.2 mg. If you are reading a trial paper, ask your prescriber or pharmacist how its doses map to the tablets on the shelf.
Missed doses
The label says to take a missed dose as soon as possible and not to double up. If 7 or more doses in a row are missed, the label says to restart the escalation at a lower dose. The Medication Guide tells patients to call their provider in that case, so the restart dose is the prescriber's decision.
Food, water, and timing: the rules that aren't there
The Medication Guide's instruction is a single sentence: "Take FOUNDAYO by mouth 1 time each day, with or without food." The label sets no water limit, no fasting window, and no time of day. Tablets should be swallowed whole and not broken, crushed, or chewed, and no more than one tablet should be taken per day.
The contrast with oral semaglutide is real. The Wegovy tablets label requires an empty stomach in the morning, no more than 4 ounces of water, and a 30-minute wait before food, drinks, or other oral medicines. Orforglipron is a small non-peptide molecule, so its absorption does not depend on those conditions. For people who take several morning medicines, that difference may matter more than any trial result.
Comparing oral GLP-1 options?
See which providers currently prescribe Foundayo and what they charge.
Paid links. We may earn a commission; it never changes what we write. See all options. Compounded medications are not FDA-approved.
The boxed warning
Foundayo carries a boxed warning for risk of thyroid C-cell tumors, like every approved GLP-1 receptor agonist for weight. The wording is unusual, though. The label states that orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodent studies. The warning is there because tumors were seen with other GLP-1 drugs in rodents and "the human relevance ... has not been determined."
In practice, the consequences are the same as for the injectables:
- Foundayo is contraindicated in anyone with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Patients should report a neck lump, trouble swallowing, shortness of breath, or hoarseness that doesn't go away.
- The label calls routine calcitonin blood tests or thyroid ultrasound of "uncertain value" for catching MTC early.
The FDA also wants more data. Its approval letter requires a medullary thyroid carcinoma registry case series lasting at least 15 years, with a final report due in August 2043.
Contraindications and warnings
The label lists only two contraindications: personal or family history of MTC or MEN 2, and a known serious allergy to orforglipron or any ingredient in the tablet. Its warnings section covers the familiar GLP-1 list:
- Acute pancreatitis. Stop the drug and call the provider for severe abdominal pain that may spread to the back.
- Severe gastrointestinal reactions. Foundayo is not recommended in severe gastroparesis.
- Acute kidney injury from dehydration. Vomiting and diarrhea can cause it.
- Low blood sugar, mainly when combined with insulin or sulfonylureas.
- Serious allergic reactions.
- Diabetic retinopathy complications in people with type 2 diabetes.
- Gallbladder disease.
- Pulmonary aspiration during anesthesia or deep sedation, because the drug slows stomach emptying. Tell the surgical team you take it.
Liver safety is also under watch. The approval letter asks Lilly for five years of enhanced pharmacovigilance on drug-induced liver injury, with serious unexpected cases reported as 15-day alerts. The label says Foundayo is not recommended in severe hepatic impairment (Child-Pugh C). No dose change is needed for mild or moderate impairment or for any degree of kidney impairment.
Drug interactions that change the dose
This is the section most likely to affect someone already on other medicines. Orforglipron is cleared partly through the CYP3A4 enzyme, and the label adjusts dosing around that.
| Interacting drug or group | What the label says |
|---|---|
| Strong CYP3A4 inhibitors | Maximum Foundayo dose of 9 mg daily |
| Strong CYP3A4 inhibitors that also block OATP1B (for example, ritonavir) | Avoid |
| Strong CYP3A4 inducers | Avoid |
| Moderate CYP3A4 inducers | Monitor effectiveness; escalate the dose as needed |
| Simvastatin | Do not exceed 20 mg daily (exposure to active simvastatin acid rose about 2 to 2.5 times) |
| Oral hormonal contraceptives | Switch to a non-oral method or add a barrier method for 30 days after starting and after each dose increase |
| Insulin or sulfonylureas | Consider lowering their dose when starting Foundayo |
| Other oral medicines | Absorption may change because stomach emptying slows |
Source: Foundayo US Prescribing Information, sections 2 and 7.
The birth control rule deserves attention. The Medication Guide says "Birth control pills by mouth may not work as well while taking FOUNDAYO." Because Foundayo is titrated in up to five steps, the backup window reopens with every increase. Non-oral hormonal methods such as patches, rings, implants, and IUDs are not expected to be affected.
The label's own examples are clarithromycin, an antibiotic, as a strong CYP3A4 inhibitor and ritonavir, an HIV medicine, as an inhibitor to avoid. A pharmacist can check your full medication list against this table in a few minutes.
Pregnancy and breastfeeding
The label says Foundayo may cause fetal harm and should be stopped once pregnancy is recognized, noting that "weight loss offers no benefit to a pregnant patient." It recommends effective contraception during treatment and says Foundayo is not recommended while breastfeeding. The FDA has required a pregnancy exposure registry and a breast milk study as postmarketing studies, so these sections may change as data come in.
Side effects, by dose
The label's adverse reaction table pools placebo-controlled trials. Side effects rose with dose, and most were gastrointestinal.
| Side effect | Placebo | 5.5 mg | 9 mg | 17.2 mg |
|---|---|---|---|---|
| Nausea | 10% | 26% | 34% | 35% |
| Constipation | 9% | 20% | 27% | 24% |
| Diarrhea | 11% | 21% | 23% | 25% |
| Vomiting | 4% | 13% | 21% | 24% |
| Indigestion | 4% | 12% | 16% | 13% |
| Stopped due to side effects | 3% | 6% | 9% | 10% |
Source: Foundayo US Prescribing Information, section 6.1.
The label also reports a heart rate increase of about 4 to 5 beats per minute, low blood pressure in 2% of patients versus 0.5% on placebo, and hair loss in 4% to 5% versus 2% on placebo.
What it costs, as of October 2026
Lilly lists these LillyDirect self-pay prices per 30 days: $149 for 0.8 mg and 2.5 mg, $199 for 5.5 mg, and $299 for 9 mg. The 14.5 mg and 17.2 mg doses are $299 if refilled within 45 days, otherwise regular pricing applies. Lilly says the 2.5 mg and 5.5 mg prices are temporarily reduced through December 31, 2026. With commercial coverage for Foundayo, the savings card can bring the cost to as low as $25 a month; government-insured patients are excluded.
See current Foundayo pricing
Compare self-pay and insurance routes from providers that prescribe it.
Paid links. We may earn a commission; it never changes what we write. See all options. Compounded medications are not FDA-approved.
Frequently asked questions
Does Foundayo have to be taken on an empty stomach?
No. The Medication Guide says to take it once a day with or without food, and the label sets no water limit or time of day. Tablets should be swallowed whole.
Is Foundayo approved for type 2 diabetes?
Not as of October 2026. Its only FDA indication is chronic weight management in adults with obesity, or overweight plus at least one weight-related condition.
Does Foundayo have a boxed warning?
Yes, for thyroid C-cell tumors. The label notes orforglipron did not cause tumors in rodents, but it is still contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2.
Does Foundayo affect birth control pills?
The label says oral contraceptives may not work as well. It advises switching to a non-oral method or adding a barrier method for 30 days after starting and after each dose increase.
What happens if I miss several doses of Foundayo?
Take a missed dose as soon as possible without doubling up. If 7 or more doses in a row are missed, the label says to restart escalation at a lower dose, so call your prescriber.
Sources
- Foundayo (orforglipron) US Prescribing Information and Medication Guide, Eli Lilly
- FDA approval letter, NDA 220934 (April 1, 2026)
- Lilly Medical: Is Foundayo approved and is it available?
- Drugs.com: Foundayo FDA approval history
- Fierce Healthcare: Lilly launches oral GLP-1 across US
- LillyDirect: Foundayo pricing
- Wegovy (semaglutide) tablets prescribing information, FDA
Medical disclaimer: This article is general information, not medical advice, and does not replace a licensed clinician who knows your history. Approvals, labels, coverage and prices change; check the linked sources and talk with your prescriber or pharmacist before making decisions about any medication.